FDA approves Pfizer COVID-19 pill, now first at-home treatment in US

Dec 22, 2021

Ben Burke Producer

By Ben Burke (Producer)

The Food and Drug Administration (FDA) approved the Pfizer COVID-19 pill for emergency use Wednesday. The video above shows clips of the White House COVID-19 Response Team discussing the approval. This marks the first time U.S. health regulators have approved an at-home treatment for COVID-19 since the pandemic began.

“This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19,” FDA Center for Drug Evaluation and Research Director Dr. Patrizia Cavazzoni said in a news release.

The pill, called Paxlovid, is approved for adults and children ages 12 and older with a positive COVID-19 test “and who are at high risk for progression to severe COVID-19, including hospitalization or death.” The weight minimum for kids getting the Pfizer COVID-19 pill is 88 lbs. According to the release, it’s available “by prescription only” and it should only be taken “within five days of symptom onset.”

“If you go outside that window of time I fully expect the effectiveness of this drug is going to fall,” Johns Hopkins University virologist Andrew Pekosz warned. In the FDA release, officials provided their own warnings regarding the Pfizer COVID-19 pill.

“Paxlovid is not authorized for the pre-exposure or post-exposure prevention of COVID-19 or for initiation of treatment in those requiring hospitalization due to severe or critical COVID-19,” the FDA wrote. “Paxlovid is not a substitute for vaccination in individuals for whom COVID-19 vaccination and a booster dose are recommended.”

Pfizer currently has 180,000 treatment courses available worldwide. Roughly 60,000-70,000 of those are allocated to the U.S. Federal health officials are expected to ration early shipments to the hardest hit parts of the country.

An antiviral pill from Merck is also expected to soon win authorization. However, Pfizer’s drug is all but certain to be the preferred option because of its mild side effects and superior effectiveness. It was shown to reduce hospitalizations and deaths among patients most likely to get severe disease by nearly 90%.

“The efficacy is high, the side effects are low and it’s oral. It checks all the boxes,” Dr. Gregory Poland of the Mayo Clinic said. “You’re looking at a 90% decreased risk of hospitalization and death in a high-risk group — that’s stunning.”

Tags: Pandemic

Jeff Zients, White House COVID-19 coordinator: “We got good news today with the authorization of Pfizer’s antiviral. Merck’s pill, if authorized, along with Pfizer’s newly authorized pill add oral treatment options to our nation’s medicine cabinet. As soon as emerging science showed the promise of these antivirals, we acted quickly and aggressively to pre-purchase 10 million treatment courses of Pfizer and three million courses of Merck.”

“Knowing that these pills take time to manufacture, Pfizer continues to increase their production plans. And now that the pill is authorized, we’ll have discussions to explore how we can help them improve their manufacturing capacity even further by providing any resources needed. We will have 265,000 treatment courses of Pfizer available in January, with monthly totals of pills ramping up across the year and all 10 million treatment courses delivered by late summer. As quickly as Pfizer gets the pills manufactured and delivered, we will immediately provide them to states and jurisdictions for distribution. Just as we’ve done with vaccines and monoclonal antibody treatments, we will ensure equity is at the center of antiviral distribution.”

Dr. Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases: “Small molecule antivirals are available now. You heard the recent approval of an EUA of paxlovid. Of note and underappreciated is Remdesivir, is already fully approved and is available in a three-day course, which in a recent study showed to dramatically diminish the need for hospitalization.”

“It is obviously a very difficult situation when you have a limited supply. For that reason, we’ve asked the NIH guidelines committee to put together a recommendation of when someone comes in with an acute infection and is in a risk group, which is what you want this to be for, since we have a limited supply, that we would have a prioritization of what the best approach would be. It almost certainly will be a physician writing a prescription for someone who within the first three days of notable symptoms of covid and is in a high-risk group to get it. But those guidelines, which will not only be limited to what you would do with paxlovid but also whether or not it would might be more appropriate to recommend remdesivir, which can be given in a three day course or one of the monoclonal antibodies that work.”

Dr. Rochelle Walensky, Director, U.S. Centers for Disease Control and Prevention: “What I can tell you is that you are 10 times more likely to have a case of covid if you are unvaccinated compared to if you are vaccinated and boosted. You are 20 times more likely to die of covid if you are unvaccinated compared to if you’re vaccinated and boosted. And yes, we know with omicron that has more mutations and is able to evade our vaccines better, that we are going to see vaccinated and even boosted people have breakthrough cases. And they will have breakthrough cases with mild and mild disease or perhaps even asymptomatic disease. And what I would say that is those vaccines working and working well, because those vaccines are working to prevent really severe disease and to prevent hospitalizations and deaths.”